Recalls / Class II
Class IID-984-2014
Product
HYDROCORTISONE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603389919.
- Affected lot / code info
- HYDROCORTISONE, Tablet, 5 mg has the following codes: Pedigree: AD60272_13, EXP: 5/22/2014; Pedigree: W002729, EXP: 6/6/2014; Pedigree: AD21790_16, EXP: 5/1/2014; Pedigree: W003060, EXP: 6/12/2014; Pedigree: W003325, EXP: 6/18/2014.
Why it was recalled
Labeling: Label Mixup: HYDROCORTISONE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: carBAMazepine ER, Tablet, 200 mg, NDC 51672412401, Pedigree: AD60272_7, EXP: 5/22/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: W002728, EXP: 4/30/2014; glyBURIDE, Tablet, 1.25 mg, NDC 00093834201, Pedigree: AD21790_10, EXP: 2/28/2014; ACARBOSE, Tablet, 25 mg
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 250 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-984-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.